drugset / Trial / NCT01646281

Vernakalant Versus Flecainide: Atrial Contractility

NCT01646281

Phase 4 Unknown 70 enrolled Maastricht University Medical Center
RandomizedParallel-groupSingle-blindDiagnostic

Summary

Atrial fibrillation (AF) is associated with decreased atrial contractility which is associated with stroke. Decreased contractility becomes apparent after cardioversion of atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved contractility immediately after cardioversion may prevent arrhythmia progression. In addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to convert atrial fibrillation to sinus rhythm and at the same time increase atrial contractility. The latter has not yet been shown in humans and is subject of the present investigation. Our hypothesis is that in humans the contractility of the atria is higher after administration of vernakalant compared to flecainide. If indeed vernakalant improves atrial contractility after cardioversion further studies into the effect on long-term arrhythmia progression and stroke prevention may follow.

Timeline

Start
2012-08
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vernakalant Other / unclassified 3 mg/kg
Comparator flecainide Small molecule 2 mg/kg

Indications